tipranavir

Trade name: aptivus

Small moleculeapproved

Approved

Jun 22, 2005

Tipranavir (PNU-140690, trade mark APTIVUS) is a potent, orally bioavailable nonpeptidic HIV protease inhibitor of the 5,6-dihydro-4-hydroxy-2-pyrone sulfonamide class. Tipranavir has potent in vitro activity against a variety of HIV-1 laboratory strains and clinical isolates, including those resistant to ritonavir, as well as HIV-2. The drug is launched in several countries, including the US and in the EU. APTIVUS, co-administered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. — NCATS

Clinical trial activity

60 trials · 15 clinical orgs · 1 marketing orgs

Phase 1
34
Phase 2
19
Phase 3
11
Phase 4
3

Earliest trial started Jan 1, 1999 (NCT02238314)

Timeline

1990s

  1. Jan 1, 1999

    Boehringer Ingelheim — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2000

    Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2003

    Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

  3. Jun 22, 2005

    Boehringer Ingelheim — Earliest FDA Approval

  4. Jun 22, 2005

    Boehringer Ingelheim — NDA Secondary Org

  5. Jun 22, 2005

    Boehringer Ingelheim — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedJun 22, 2005

Chemistry & pharmacology

Loading structure…

SMILES

CCC[C@@]2(CCC1=CC=CC=C1)CC(O)=C([C@H](CC)C3=CC=CC(NS(=O)(=O)C4=NC=C(C=C4)C(F)(F)F)=C3)C(=O)O2
Mol. weight
602.664 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3'-((1r)-1-((6r)-5,6-dihydro-4-hydroxy-2-oxo-6-phenethyl-6-propyl-2h-pyran-3-yl)propyl)-5-(trifluoromethyl)-2-pyridinesulfonanilide
  • aptivus
  • aptivus
  • aptivus
  • aptivus
  • aptivus
  • pnu 140690
  • pnu 140690
  • pnu-140690
  • pnu-140690
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir
  • tipranavir, (r-(r*,r*))-isomer
  • tipranavir, (s-(r*,r*))-isomer
  • tipranavir, (s-(r*,s*))-isomer
  • tipranivir
  • u-140690
  • u-140690

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03631732Phase 3Aug 28, 2018Gilead Sciences
NCT01923311Phase 2/Phase 3 (Phase 3)Aug 26, 2013Gilead Sciences
NCT01743521Phase 4Jan 1, 2013Johnson and Johnson, University of New South Wales
NCT00708162Phase 3Jul 1, 2008Gilead Sciences
NCT02244190Phase 1Apr 1, 2008Boehringer Ingelheim
NCT00537394Phase 3Jan 1, 2008AIDS Clinical Trials Group, Brown University, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Diego
NCT00607958Phase 4Dec 1, 2007Badalona Hospital Germans Trias i Pujol, Fundacio Lluita Contra la SIDA
NCT00530920Phase 2Oct 1, 2007Boehringer Ingelheim
NCT00517192Phase 3Sep 1, 2007Boehringer Ingelheim
NCT02251795Phase 1Aug 1, 2007Boehringer Ingelheim
NCT00447902Phase 3Mar 1, 2007Boehringer Ingelheim
NCT00440271Phase 3Feb 1, 2007Boehringer Ingelheim
NCT00344123Phase 1Feb 1, 2007Boehringer Ingelheim, Johns Hopkins University
NCT02226978Phase 1Feb 1, 2007Boehringer Ingelheim
NCT02229760Phase 1/Phase 2 (Phase 2)Aug 1, 2006Boehringer Ingelheim
NCT00486330N/AMay 1, 2006Boehringer Ingelheim, Yale University
NCT02226991Phase 1Apr 1, 2006Boehringer Ingelheim
NCT02227017Phase 1Feb 1, 2006Boehringer Ingelheim
NCT02259855Phase 1Jan 1, 2006Boehringer Ingelheim
NCT02243553Phase 1Jan 1, 2006Boehringer Ingelheim
Showing 20 of 60 trials
Page 1 / 3

Organizations

Research & Development (15)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit525041999
Gilead SciencesFor profit3312008
Badalona Hospital Germans Trias i PujolAcademic/Hospital2222005
Fundacio Lluita Contra la SIDAAcademic/Hospital2022005
University of New South WalesAcademic/Hospital2212003
AIDS Clinical Trials GroupAcademic/Hospital1012008
Brown UniversityAcademic/Hospital1012008
Johns Hopkins UniversityAcademic/Hospital1112007
Johnson and JohnsonFor profit1012013
National Heart, Lung, and Blood Institute (NHLBI)Government1012003
National Institute of Allergy and Infectious Diseases (NIAID)Government1112008
The National Centre in HIV Epidemiology and Clinical Research, SydneyAcademic/Hospital1012003
University of BarcelonaAcademic/Hospital1012005
University of California, San DiegoAcademic/Hospital1012008
Yale UniversityAcademic/Hospital1112006
15 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Boehringer IngelheimFor profitNDA2Jun 22, 2005
Boehringer IngelheimFor profitNDAJun 22, 2005